Quality & Validation

An exciting new opportunity has become available for a Validation Engineer in a market leading medical device firm. Candidate's responsibilities will be to manage and support assigned projects through validation to completion and will receive general guidance from functional management.

Validation Engineer Responsibilities;

* Provide support to production and R&D ensuring new and existing products and equipment meet the companies' current validation requirements.
* Write and execute validation documents
* Liaise with other departments to ensure the processes and procedures needed to maintain validated systems are established, understood and implemented.
* To lead and perform validation activities ensuring validation assignments include validation and qualification of new and existing facilities, utilities, products, processes, manufacturing, packaging and computer systems.
* Writing of related project documentation and protocols for installation, operation and performance qualifications, validation plans and reports.
* Continuously be looking to support continuous validation improvement activities-Execution of validation operations for manufacturing equipment, packaging, utility equipment, processes, initial cleaning validation, and any other study identified in accordance with current Good Manufacturing Practices, MHRA requirements and Change Control.
* The Validation Engineer will have significant experience in the validation and qualification of manufacturing/packaging equipment, computer systems validation, utility systems qualification and process validation.
* This job is based on days but will require flexibility to service a 24/7 factory.
* This position reports into the Engineering Department.

Validation Engineer Requirements;

* At least 2 years experience in a manufacturing environment role. Ability to make decisions within a pressurised environment.
* Able to build strong relationships at all levels with strong communication and influencing skills
* Experience in the validation of manufacturing processes and the associated scale up activities
* Audit consultant experience in ISO13485, MDD93/42/EEC & ISO9001

If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to send your up to date CV or contact me on 0207 758 7322To find out more about Real please visit www.realstaffing.com